|Place of Origin:||CN|
|Certification:||ISO 13485, CE|
|Minimum Order Quantity:||500|
|Price:||US 2.80 Kit|
|Packaging Details:||Paper Box|
|Delivery Time:||7 Days|
|Product Name:||AMH Rapid Test Kit||Pack:||25 Tests|
|Sample Diluent:||Whole Blood Buffer||Storage:||4-30℃|
|Advantage:||High Sensitivity, High Accuracy||Application In:||WWHS NIR-1000 Dry Fluoroimmunoassay Analyser|
|Throughput:||300 Tests / Hour||Keyword:||Fertility Rapid Test Kit|
|Manufacturer:||WWHS Biotech INC||Annual Capacity:||3 Million A Year|
One Step Fertility Test Kit,
300 Tests / Hour Fertility Test Kit,
AMH Rapid Test Cassette
Anti-Mullerian Hormone (AMH) Rapid Quantitative Test (Fluorescence immunoassay)
The kit is used for quantitative determination of AMH in human whole blood,serum or plasma. It is mainly used to evaluate ovarian reserve and assist in the diagnosis of polycystic ovary syndrome .
The Diagnostic Kit for AMH is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of AMH. The AMH antigen in the sample was first bound with the conjugated compound of fluorescent labeled AMH monoclonal antibody, then moved and combined with another AMH monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||The product consists of fluorescent pat (coated with fluorescently-labeled AMH antibody), nitrocellulose membrane (coated with AMH antibody and Goat anti mouse IgG antibody), absorbent paper and PVC soleplate.|
|Sample diluent||25 (0.3mL/ tube)||Phosphate buffer|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【Storage Conditions and Validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Test and analyze the AMH from healthy people serum, and use the 95 percentile method to determine the AMH reference interval.
|Sex||Age||Reference Interval (ng/mL)|
It is strongly recommended that each laboratory should determine its own normal and abnormal values.
【Interpretation of test results】
【Limitation of test method】
3. The triglyceride content in the sample does not exceed 15mg/mL, the hemoglobin content does not exceed 10mg/mL, the bilirubin content does not exceed 0.5mg/mL, the cholesterol does not exceed 10mg/mL, and the relative deviation of the measurement results does not exceed ±15.0%.
4. When AMH concentration of samples reaches 160.00ng/mL, there is no hook effect.
6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±10.0%.
7. For samples exceeding the linearity range, test cannot be conducted after dilution.
8. Inhibin A (≤100ng/mL), Activin A (≤100ng/mL), LH (≤500mIU/mL), FSH (≤500mIU/mL) several commonly used drugs in the sample (Cefoxitin ≤2500mg/ L. Metformin≤2000mg/L, ibuprofen≤500mg/L, rifampicin≤60mg/L, doxycycline≤50mg/L), the relative deviation of the measurement results does not exceed ±15.0%
1. Limits of detection
No higher than 0.10ng/mL
The relative deviation to the target value is limited to ±15.0%.
The within and between assay coefficient of variations are within 15%.
Within the linear range (0.10 ~ 16.00) ng/mL, the linear correlation coefficient R≥0.990.
1. The kit can be used for in vitro diagnosis only.
2. Test card and buffer solution are single-use and they cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.
5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.
6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.
The AMH Rapid Test Cassette (Whole Blood/Serum/Plasma) is a semi-quantitative membrane based
immunoassay for the detection of anti-Mullerian Hormone in whole blood, serum or plasma. In this test
procedure, anti-AMH antibodies is immobilized in the test line region of the test. After specimen is
added to the specimen well of the cassette, it reacts with anti-AMH antibody coated colloid gold
particles in the test. This mixture migrates chromatographically along the length of the test and
interacts with the immobilized anti-AMH antibodies. If the specimen contains AMH, a colored line will
appear in the test line region indicating a positive result. If the specimen does not contain AMH, a
colored line will not appear in this region indicating a negative result. To serve as a procedural
control, a colored line will always appear in the control line region, indicating that proper volume
of specimen has been added and membrane wicking has occurred.
|cat#.||Product item||Specimen||Reaction Time||Measure Range||Clinical Range||Itended Use|
|1||cTnI||WB/Serum/Plasma||12min.||0.1-40ng/ml||<0.3ng/ml||several heart diseases including myocardial infarction and heart failure.|
|2||Myo||WB/Serum/Plasma||12min.||5-400ng/ml||<58ng/ml||acute myocardial infarction (AMI) in early stage.|
|3||CK-MB||WB/Serum/Plasma||12min.||1-200ng/ml||<5ng/ml||acute myocardial infarction (AMI) in early stage.|
|heart failure .|
|5||D-Dimer||WB/Plasma||10min.||40-10000ng/ml||<500ng/ml||disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.|
|6||cTnI+Myo+CKMB||WB/Serum/Plasma||12min.||same with single item||same with single item||Triple marker of myocardial infarction.|
|7||ST2||WB/Serum/Plasma||10min.||10-400ng/ml||<35ng/ml||heart failure .|
|8||Lp-PLA2||WB/Serum/Plasma||10min.||10-900ng/ml||<175ng/ml||Risk evaluation of ACS and atherosclerotic ischemic stroke patients.|
|9||S100-β||WB/Serum/Plasma||10min.||0.05-10ng/ml||<0.2ng/ml||Cerebral infarction, cerebral injury.|
|10||CRP / hs-CRP||WB/Serum/Plasma||3min.||0.5-200mg/L||CRP<10mg/L,hs-CRP<1mg/L||nonspecficity inflammatory marker.|
|13||CRP+SAA||WB/Serum/Plasma||5min.||same with single item||same with single item||inflammation&infection.|
|15||TSH||Serum/Plasma||15min.||0.3-100mU/L||0.35-5mU/L||hyperthyroidism and hypothyroidism|
|21||CEA||Serum/Plasma||15min.||1-200ng/ml||<5ng/ml||colon cancer, colorectal cancer,etc.|
|22||NSE||Serum/Plasma||15min.||1-400ng/ml||<16ng/ml||non-small cell lung cancer|
|23||FOB||fecal specimens||10min.||50-1000ng/ml||<100ng/ml||Abnormal recessive gastrointestinal bleeding|
|24||PG II||Serum/Plasma||15min.||1-100ug/L||PGI/PGII>3.0||gastric abnormalities|
|25||PG I||Serum/Plasma||15min.||2.5-200ug/L||>70ng/ml||gastric abnormalities|
|29||CA15-3||Serum/Plasma||15min.||10-400U/ml||< 25 U/mL||breast cancer|
|30||HE4||Serum/Plasma||15min.||50-2000pmol/L||<140 pmol/L||ovarian cancer|
|31||CA19-9||Serum/Plasma||15min.||10-400U/ml||< 27 U/mL||pancreatic cancer|
|32||β-HCG||Serum/Plasma||15min.||5-400mIU/ml||<10 mIU/mL||Early pregrancy, ectopic HCG cancer,incomplete abortion|
|33||CK19(Cyfra21-1)||Serum/Plasma||15min.||0.5-50ng/ml||<2.5ng/ml||non-small cell lung cancer|
|34||HCG / β-HCG||Serum/Plasma||10min.||5-20000mIU/ml||<5 mIU/mL||early pregrancy.|
|35||AMH||Serum/Plasma||10min.||0.1-16ng/ml||Male: 20-60 years old, 0.92-13.89 ng/mL
Female: 20-29 years old, 0.88-10.35 ng/mL
30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL
|ovarian reserve level|
|36||FOB||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|37||TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|38||FOB+TRF||fecal specimens||10min.||qualitative||qualitative||gastrointestinal hemorrhage.|
|41||Covid-19 Antigen||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|42||Covid-19 Ab IgG/IgM||WB/Serum/Plasma||15min.||qualitative||qualitative||respiratory tract|
|43||FluA||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|44||FluB||nasal swab, throat swab or nasal wash/aspirate specimens||15min.||qualitative||qualitative||respiratory tract|
|46||NGAL||Urine||10min.||10-1500ng/mL||<132ng/mL||acute kidney injury.|
|iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia|
About NIR-1000 Dry Fluoroimmunoassay Analyser
It is a fluorescence immunochromatographic analysing system with internal temperature control,
which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.
Testing time less than 15 minutes
1. High Quality: Imported Major Components with Advanced German Technology
2.User-Friendly Design: 7 Inch touch screen, great touch feeling, simple graphic interface
3. Built-In Lithium Battery: High Mobility for first aid&amulance
4. Two Test Mode: Internal&External mode for different clinical needs
5. Smart Report: Auto Printing
6. Visual Results: Able to connect with LIH/HIS
1.How to buy your products?Do you have distributor in our country?
You can buy the products from our company directly.Normally the procedure is:Sign the contact ,payment byT/T, contact the shipping company to delivery the goods to your country.
2. What is the warranty?
The free warranty is one year from the day of Commissioning qualified.
3.Can we visit your country?
Of course,we will prepare for everything in advance if it is necessary .Generally,it is require that customers must have build agency relationship or business relationship with our company.
4.How long is the validity of quotation?
Generally,our price is valid within one month from the date of quotation .The price will be adjusted appropriately according to the price fluctuation of raw material and changes in market.
5.Do you have the CE certificate?
Yes, most of our products have the CE certificate.
Contact Person: sales
Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen
Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen